Petri M The last EULAR/ACR recommendations recommended use of the PGA in the routine monitoring of SLE [16]. No study has evaluated the correlation of PGA with damage measures. , Hochberg M. Wallace DJ , Genovese M , Mina R Few studies reported on whether serological activity should be incorporated in the PGA. , Magder L FitzGerald and Grossman [10] found a good interRR in a retrospective assessment of the PGA (=0.79). Mina R Content validity was reported in 89 studies. T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. Patient-Reported Outcomes in Systemic Lupus Erythematosus. All rights reserved. Navarra SV The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. Thank you for submitting a comment on this article. The visual analog scale (VAS)-based assessments, SELENA SLE Disease Activity Index (SLEDAI) Physician's Global Assessment (SSPGA) and Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL), can be used to assess common trial end points for systemic lupus erythematosus (SLE), according to study results published in Lupus Science & Medicine. , Ibanez D Face validity. official website and that any information you provide is encrypted , Mikolaitis-Preuss RA , Allen E , Sengupta M , Morabito LM , Jolly M. Antony A The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Int J Environ Res Public Health. et al. For permissions, please email: journals.permissions@oup.com, This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (. , Kalunian K , Voskuyl A [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. Gordon C Help us improve CareerBuilder by providing feedback about this job: Report this job Job ID: 2281236908. 2) [10, 23, 24, 26, 28, 29, 35, 54, 68, 76, 84, 99], with the SLAM in 4 studies (r=0.470.65) [35, 76, 84, 99], with LAI in 2 studies (r=0.640.75) [68, 84], with BILAG in 2 studies (r=0.610.62) [35, 84] and with ECLAM in 2 studies (r=0.580.65) [35, 84]. We analysed the performance of the SELENA SLEDAI Physician's Global Assessment (SSPGA) and the Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL) as measures . RN-BSN HOLISTIC HEALTH ASSESSMENT ACROSS THE LIFESPAN (NURS 3315) Sociology of Social Problems (SOC213) , Perez-Gutthann S disease activity). , Wetter J Elisabetta Chessa, Matteo Piga, Alberto Floris, Herv Devilliers, Alberto Cauli, Laurent Arnaud, Use of Physician Global Assessment in systemic lupus erythematosus: a systematic review of its psychometric properties, Rheumatology, Volume 59, Issue 12, December 2020, Pages 36223632, https://doi.org/10.1093/rheumatology/keaa383. The Physician Global Assessment (PGA) of treatment response measures the overall response to treatment as assessed by the physician. , Siega-Riz AM In one study [25], the PGA of disease activity resulted from the combination of the clinical visit, laboratory markers evaluation and the physicians knowledge of the patient disease history. Impact of anti-SARS-CoV-2 antibodies of different isotypes (IgA, IgG, IgM) on attainment of PGA . et al. et al. PMC , Brunetta P They participate in physiologic and inflammatory cascades and have become a major focus of research, yielding novel therapies for immune-mediated inflammatory diseases (IMID). This property is reported across all articles selected through this systematic review [24, 913, 21103]. , Magder LS The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. , Magder LS Please enable it to take advantage of the complete set of features! A difference between the interRR of the PGA assessed by an untrained physician (ICC=0.50.63) or a trained investigator (ICC=0.790.81) was found [36]. watch for seizures after the procedure. They proposed a physician global score on a 10cm visual analogue scale (VAS) to be used as a gold standard to compare six disease activity instruments [4]. , Petri M. Foering K http://oml.eular.org/glossary (31 January. Several definitions of minimum clinically important difference were retrieved: in the SRI-4, a significant worsening was defined as an increase of >10% on the PGA-VAS [111], corresponding to 0.3 points from baseline; Touma et al. Reviews and case series with fewer than five patients were excluded. The literature search identified 93 articles, and 12 additional articles were retrieved from the reference list of those publications. The Author(s) 2020. Montreal, Canada Area. A Comprehensive Digest of Research Publications From Cedars-Sinai Investigators. Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. Vashisht P Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. The authors wish to thank Sylvie Thuong for her invaluable assistance in the preparation of this manuscript. 2022 Sep;8(2):e002395. , Landis RC Enocsson H Disclosure statement: L.A. is a consultant for Alexion, Amgen, AstraZeneca, GlaxoSmithKline, Janssen-Cilag, LFB, Eli Lilly, Menarini France, Novartis, Pfizer, Roche-Chugai and UCB. Injuries requiring medical treatment are considered to be "reportable incidents," and must be reported to the NJDOE within five working days of the occurrence. 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Face validity was reported in all the articles retrieved in which the PGA was used alone or as part of composite indices (Systemic Responder Index, Safety of Estrogen in Lupus Erythematosus National Assessment Flare Index, Lupus Low Disease Activity State, Definitions of Remission in Systemic Lupus Erythematosus criteria). PGA is often assessed by a single question with a 0-10 or 0-100 response. , Saad-Magalhes C 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. et al. , Annapureddy N Kandane-Rathnayake R, Louthrenoo W, Hoi A, Luo SF, Wu YJ, Chen YH, Cho J, Lateef A, Hamijoyo L, Navarra SV, Zamora L, Sockalingam S, An Y, Li Z, Katsumata Y, Harigai M, Hao Y, Zhang Z, Kikuchi J, Takeuchi T, Basnayake BMDB, Chan M, Ng KPL, Tugnet N, Kumar S, Oon S, Goldblatt F, O'Neill S, Gibson KA, Ohkubo N, Tanaka Y, Bae SC, Lau CS, Nikpour M, Golder V, Morand EF; Asia-Pacific Lupus Collaboration. The site is secure. Identification of new candidate drugs for primary Sjgrens syndrome using a drug repurposing transcriptomic approach, When it looks like Behets syndrome but is something else: Differential diagnosis of Behcets syndrome: a two-centre retrospective analysis, Huge water-balloons in the belly: multiple pancreatic pseudocysts in systemic lupus erythematosus, A randomized, double-blind, placebo-controlled, parallel group study on the effects of a cathepsin S inhibitor in primary Sjgrens syndrome, How to plug the leaky pipeline in clinical rheumatology across Europelessons to be learned from experiences in business, About the British Society for Rheumatology, British Society for Rheumatology Journals, https://doi.org/10.1093/rheumatology/keaa383, https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model, Receive exclusive offers and updates from Oxford Academic, Copyright 2023 British Society for Rheumatology. , Fang H , Larson MG 1 2. The PGA was developed on a 0 to 3 scale as part of the Lupus Activity Index. [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. Introduction Physician global assessments of disease activity (medical doctor (MD) globals) are important outcomes. No study has evaluated the feasibility of the PGA in SLE to date. According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. , Carpenter AB sharing sensitive information, make sure youre on a federal Rheumatology (Oxford). Some may be a consequence of therapy and others may be . Ensure second line of defense Derivatives RWA reviews are performed consistently and . CareerBuilder TIP. Fanouriakis A This study assesses the reliability of the PGA, measured by means of 0-100 mm visual analog scale (VAS), and the additional use of separate VAS scales for musculoskeletal (PhysMSK) and dermatologic (PhysSk) manifestations in patients with psoriatic arthritis (PsA). Disclaimer. , Engleman EG The literature search identified 91 studies. The term Physician Global Assessment (PGA) was coined in 1991 by Petri et al. . The LUMINA (Lupus in Minorities: Nature versus Nurture) study and other trials have offered evidence of a decrease in flares and prolonged life in patients given hydroxychloroquine, making . Arriens C 25 (FIVE YEARS 8) Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords Latest Documents; Most Cited Documents; Contributed Authors; Related Sources; Jiao H, Acar G, Robinson GA, Ciurtin C, Jury EC, Kalea AZ. , Smiley A. Askanase AD , Navarra SV The last MEDLINE search was performed on 1 July 2019. Criterion validity data reporting correlation coefficients between PGA and quality of life measures, laboratory markers and miscellaneous. , Urowitz MB All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. Prinsen CAC et al. Construct validity was recognized in 21 studies [2, 10, 11, 23, 24, 2629, 35, 47, 52, 54, 65, 68, 76, 84, 88, 92, 99, 101]. , Hochberg M. Touma Z Matthew Turk,1,2 Janet E Pope1,2 To cite: turk M, Pope Je. This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88]. In one open-label study [43], the decrease in PGA score was considered the primary endpoint. , Wallace DJ Construct validity was demonstrated by a good correlation (r0.50) between the PGA with the SLEDAI (12 studies), SLAM (4 studies), LAI, BILAG and ECLAM (2 studies each). Physician global assessments for disease activity in rheumatoid arthritis are all over the map! , Farewell V , Chakravarty E This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. et al. Touma Z , Gordon C , Matos A Conducting medical monitoring, safety review, narrative writing and etc.. Perform medical assessment of individual . , Chatzidionysiou K Annapureddy N , Magder LS et al. Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. physician's global assessment (PGA) of disease activity in SLE. SLE is an immune-mediated multisystemic disease characterized by a wide variability of clinical manifestations and a course frequently subject to unpredictable flares [1, 2]. The aim of this systematic review is to describe and analyse the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. Over the years, PGA-IGA scales were modified for the purpose of clinical settings and thus present a diversity in the number of response options (4 to 10 points), the response options label and the . Can Lupus Patients Take the Driver's Seat in Their Disease Monitoring. Correspondence to: Laurent Arnaud, Service de Rhumatologie, Centre National de Rfrence des Maladies Autoimmunes et Systmiques Rares, Hpital de Hautepierre, 1 Avenue Molire BP 83049, 67098 Strasbourg Cedex, France. , Engel SM The SRI is a composite instrument comprised of the SELENA-SLE Disease Activity Index [SELENA-SLEDAI], Physician Global Assessment (PGA) and British Isles Lupus Assessment Group (BILAG) 2004. Glossary: PGA. Trusted for over 30 years to provide and transform technology into complete solutions that advance the value of IT. Higher disease activity is an important predictor of both organ damage and mortality [2] and the attainment of low disease activity is associated with a reduction in early damage [5, 6]. Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. The literature search identified 91 studies. Direkt zum Inhalt springen . A PGA >1 was predictive of polymorphic light cutaneous eruption (P=0.02) [59] and correlated negatively with LLDAS attainment [37]. An international panel of 79 SLE experts participated in a three-round Delphi consensus process, in which 41 statements related to the PGA in SLE were . For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. et al. In 32 studies, disease activity measured by PGA was compared with changes in laboratory markers, with the aim of correlating clinical and serological features [9, 21, 30, 32, 34, 3739, 44, 45, 48, 49, 55, 5861, 63, 64, 66, 67, 69, 71, 74, 75, 82, 86, 89, 9194]. Schlencker A, Messer L, Ardizzone M, Blaison G, Hinschberger O, Dahan E, Sordet C, Walther J, Dory A, Gonzalez M, Kleinlogel S, Bramont-Nachman A, Barrand L, Payen-Revol I, Sibilia J, Martin T, Arnaud L. Lupus Sci Med. In this systematic review we have analysed the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. Criterion validity is defined as the degree to which the scores of an instrument adequately reflect the truth in the form of a gold standard [107]. This scoring modality was used for the SRI [3]. Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. 2. Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. The OMERACT defines an instrument as an outcome measure if it passes the three pillars of evidence: truth (that refers to validity), discrimination (that includes reliability and responsiveness) and feasibility. Reliability measures the reproducibility of the instrument: it refers to the degree of agreement between different observers (interrater) and in the same observer over time (intrarater). Brunner HI , Skogh T Brunner HI , Holland M BILAGAB . Reliability. , Mohan C. Giangreco D Aranow C , Block JA The index has proved quick and easy to use despite a comprehensive database and compares favourably with . Systemic lupus erythematosus (SLE) is a chronic autoimmune disease of multifactorial origin that can affect any organ or organ system, resulting in a broad spectrum of clinical manifestations ranging from dermatological involvement to multi-organ failure with episodes of relapses and remissions. , Engle E The anonymous patientcompleted questionnaire comprised the following: current pain in the past 7 days (10cm VAS [0 no pain; 10 most severe pain]), patient global assessment (PtGA) of health status (10 cm VAS [0 very well; 10 very poorly]), ever and current recreational cannabis use, ever and current medical cannabis use, and if cannabis . Whenever papers reported duplicate data, the most recent article was selected. PGA is a valid, responsive and feasible instrument, though its reliability was impacted by the scale adopted, suggesting the major need for standardization of its scoring. , Oon S In a post-hoc analysis of phase 3 belimumab trials, improvements and no worsening in the PGA were greater among SRI responders vs SRI non-responders (P<0.001) [52]. Criterion validity also refers to the degree to which an instrument predicts aspects and phenomena occurring in the future [108]. It does not provide a predefined or limited list of disease manifestations or organ systems, thus allowing one to capture all the heterogeneous aspects of SLE disease activity. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients age. In one study, the PGA was part of a modified score to assess disease activity in pregnancy (the SLE in Pregnancy Disease Activity Index) [51]. , Mazur M. Fatemi A et al. et al. , Kalunian K The Physician Global Assessment (PGA) has been shown to be a valid, responsive, and feasible instrument to capture disease activity in systemic lupus erythematosus (SLE), but its low reliability further supports the need for a standardisation of its scoring. National Library of Medicine , Petri MA , Cella D. van Vollenhoven RF Construct validity is shown by the good correlation observed with the SLEDAI, BILAG, SLAM, LAI and ECLAM [10, 23, 24, 26, 28, 29, 35, 54, 68, 76, 84, 99]. Management of systemic lupus erythematosus (SLE) often depends on disease severity and disease manifestations, [] although hydroxychloroquine has a central role for long-term treatment in all SLE patients. . Mertz P, Piga M, Chessa E, Amoura Z, Voll RE, Schwarting A, Maurier F, Blaison G, Bonnotte B, Poindron V, Fiehn C, Lorenz HM, Korganow AS, Sibilia J, Martin T, Arnaud L. RMD Open. 2019ACREULAR . , Jnsen A , James JA Liang et al. This site needs JavaScript to work properly. Results: Mina R In Fatemi et al. , Criscione-Schreiber LG , Birmingham DJ , Petri M. Isenberg DA Schneider M , Khamashta MA It should be noted that the PGA correlates with several other instruments that measure disease activity. Unauthorized use of these marks is strictly prohibited. et al. et al. Nevertheless, despite the fact that the PGA was considered the reference in 39 studies involving other indices, it was used as the sole instrument in only 2 of them. Exagen's products are used for therapeutic drug monitoring of hydroxychloroquine in whole blood and methotrexate polyglutamates, risk assessment testing, anti-TNF monitoring to individualize therapy and optimize dosing, and others. , Aggarwal R Background: Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. To discriminate between the severity of flares, the PGA was incorporated in a composite index: the SFI [10] (Table1). [8] suggested that the PGA should account for objective examination, laboratory results and what patients report. Methods We determined the variability of MD globals, surveying rheumatologists from the Canadian Rheumatology Association using rheumatoid . Three studies evaluated the association between PGA scores and treatment changes: PGA correlated negatively with adherence to treatment assessed through an item scale (r=0.31, P=0.11) [34]; clinically defined mild and moderate flares had a higher disease activity by the PGA (P<0.001) than those defined as mild/moderate flare only by medication changes [55]; PGA scores were associated positively with response to belimumab treatment (P=0.039) [43]. SELENA SLEDAI4. The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. Methods et al. AU - Morand, Eric. For instance, in an analysis of studies of the prevalence of SLE in the Asia-Pacific region, higher rates of renal involvement were observed in Asian patients (21-65% at SLE diagnosis and 40 . Results. For permissions, please email: journals.permissions@oup.com. If you have a published paper from this period that does not appear on this list, please contact Sue Marone, who will add it to next week's collection. , Ogale S The PGA was introduced in 1998 by a US Food and Drug Administration panel as the preferred tool to assess and record the severity of disease in clinical studies, and typically rates a patient's disease from 'clear' to 'severe' or 'very severe' [1, 2]. , Glassman DS Merrill JT A good responsiveness for PGA was shown in eight studies. It was published in 1977 and was initially designed for the measurement of self-assessed pain in rheumatoid arthritis although it has since been used to evaluate RA more globally. Results of a large, multicentric, nationwide study, American College of Rheumatology provisional criteria for global flares in childhood-onset systemic lupus erythematosus, A cross-sectional study of hydroxychloroquine concentrations and effects in people with systemic lupus erythematosus, Inactive disease and remission in childhood-onset systemic lupus erythematosus, Preliminary criteria for global flares in childhood-onset systemic lupus erythematosus, Systemic lupus erythematosus in a multiethnic US cohort, XXXVII: association of lymphopenia with clinical manifestations, serologic abnormalities, disease activity, and damage accrual, Systemic lupus erythematosus in a multiethnic cohort (LUMINA): XXIX. Supporting the face validity property, PGA was defined the gold standard in 11 studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88] and in 32 it was used as the reference to which other activity scores were compared, such as the SLEDAI [4, 10, 13, 25, 27, 28, 31, 33, 35, 36, 41, 46, 47, 50, 51, 53, 62, 65, 68, 72, 73, 76, 81, 9699], BILAG [4, 27, 35, 36, 46, 65, 72, 73, 81, 98], SLAM [4, 72, 76, 99], LAI [68, 88], patient global assessment [81, 83, 84] and ECLAM [35]. Compared with nonresponders, BICLA responders had greater improvements in global and organ-specific disease activity (Physician's Global Assessment, SLE Disease Activity Index 2000, Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity, and joint counts; all nominal P < 0.001). Keywords: In 89 studies [2, 3, 913, 21102] the PGA was used to measure disease activity as a whole, therefore satisfying the content validity criteria. Each study was examined in order to extract psychometric property data on the PGA according to the OMERACT Filter methodology version 2.1 [18]. Different scores and lengths of visual evaluation were employed: the first was the 010 VAS suggested by Liang et al. J Clin Med. In this sense, criterion validity of PGA is satisfied when scores correlate with phenomena subsequently influenced by disease activity, such as quality of life measurements (Health-related Quality of Life, 36-item Short Form Health Survey, Functional Assessment of Chronic Illness TherapyFatigue score, Lupus Impact Tracker and LupusPRO), biomarker levels (complement fractions, ESR, autoantibodies), treatment variations and damage assessments (SDI).
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